Kirk Shepard, MD, chief medical officer, senior vice president, and head of Global Medical Affairs, Eisai, discusses findings of a study showcasing similar health-related quality of life (HRQOL) scores between lenvatinib/pembrolizumab vs chemotherapy in patients with advanced endometrial carcinoma.
Results showcasing similar health-related quality of life (HRQoL) scores among patients with advanced endometrial carcinoma undergoing combination therapy vs mono-chemotherapy could prove significantly important, particularly for a disease that has not had a specifically approved therapy in 50 years, said Kirk Shepard, MD, chief medical officer, senior vice president, and head of Global Medical Affairs, Eisai.
Can you discuss what can be derived by measuring HRQoL for a condition such as endometrial cancer (EC), particularly in its advanced stages (aEC)?
It's extremely important that we measure these parameters in patients, particularly in endometrial carcinoma, advanced endometrial carcinoma. If you think about it, it's been 50 years since a drug has been specifically approved for endometrial carcinoma. So, it's very important that we just don't measure the effectiveness [and] efficacy of a drug, but also look at the risk-benefit balance, and of course quality of life is on the other side. So using the health-related quality of life measures, which have come quite far in the last couple of decades–2 guidelines, at least, written since 2006, 2009, FDA, Europe, about the measures of how they appropriately can measure quality of life in patients.
And this particular one that we used, which was the EORTC QLQ-C30, is one that's used probably more than any. It's a more of a general measure of parameters of different domains. And it's been validated in over 100 validation studies and used in maybe a couple thousand studies through a couple of decades. So, very important that we use these tools that we have now to measure the quality of life in patients.
Results indicate similar mean HRQoL scores for patients with aEC undergoing the combination therapy vs chemotherapy. Can you speak on the significance of this finding?
So, we were very happy with the results, as you might imagine, because we were comparing ourselves—Keytruda [pembrolizumab] and Lenvima [lenvatinib]—to one mono-chemotherapy. And these are traditional chemotherapies. So, it would be called the physician's choice of therapy, which is either doxorubicin or paclitaxel.
So to come out with, numerically, in fact, better quality of life—although it wasn’t statistically important—but the same quality-of-life parameters as 2 mono drugs, while we're giving 2 drugs was very important.
As I said too, this is something that's very valuable because it gives—particularly health care physicians who have treated endometrial carcinoma for 50 years with the same drugs—a window into what's happening when we offer new advanced drugs, such as an IO [immuno-oncology] or a TKI [tyrosine kinase inhibitor], such as Lenvima, and shows that, really, the quality of life remains quite good. So, with the great results we got, which I think you're probably familiar with the 309 Study we presented at SGO [Society of Gynecologic Oncology], it's really a very acceptable risk:benefit ratio.
Were there any notable differences by patient subgroup in HRQoL for those undergoing the combination therapy?
We haven't done subgroup analyses yet, and it's a great question, because that's what needs to be done first. We, of course, wanted to get the topline results out for SGO as soon as we knew the results so that treating physicians knew that this was another group of drugs they could use together to treat patients.
And then of course the quality of life is somewhat topline now also. It gives the tool that I mentioned before, the results of that. But the subgroup analysis, as long as the numbers don't get too low as we look at the group, is the way that we would want to go next as far as the next step.
I can just say that it's been a pleasure to work at a company like Eisai because they have human health care, which you may or may not have heard about. Human health care is a platform that was started 30 years ago, where we put the patient first, the caregiver, and the family.
And so this fits in very well with what we've done, not only with endometrial carcinoma, but in the same program at ASCO, we are doing a HRQoL study, and it's being orally presented for renal cell carcinoma. So again, Eisai is very concerned about not just getting good results as far as shrinking tumors, but making sure that we always consider the quality of life of the patient.
Lorusso D, Colombo N, Herraez AC, et al. Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC). J Clin Oncol. 2021;(suppl 15; abstr 5570). doi:10.1200/JCO.2021.39.15_suppl.5570